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Silver Nanoparticle Investigation for Treating Chronic Sinusitis (SNITCH)

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ClinicalTrials.gov Identifier: NCT03243201
Recruitment Status : Withdrawn (IND not approved)
First Posted : August 8, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden. Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely contributor to recalcitrant disease. Emerging evidence shows that colloidal silver nanoparticles may be effective for reducing biofilms. The investigators intend to perform a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness and safety of intranasal colloidal silver nanoparticles in adult patients with chronic rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement in symptom scores and will not be associated with increased rate of adverse effects.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Colloidal silver nanoparticles Other: Purified Water Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Intranasal Colloidal Silver Nanoparticles for Chronic Rhinosinusitis: A Proof-Of-Concept, Double-Blinded, Placebo-Controlled, Randomized Trial
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Colloidal Silver
The colloidal silver arm will administer intranasal colloidal silver, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day (8 mcg of silver per day), for 28 days.
Drug: Colloidal silver nanoparticles
Contains 10ppm colloidal silver nanoparticles
Other Name: Sovereign Silver, Bio-Active Silver Hydrosol

Placebo Comparator: Purified Water
The placebo arm will administer intranasal purified water, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day, for 28 days.
Other: Purified Water
Purified water will be given as placebo




Primary Outcome Measures :
  1. Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: Four weeks ]
    Assess change in SNOT-22 score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS):

  • mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion), facial pain-pressure-fullness, or decreased sense of smell

AND inflammation is documented by one or more of the following findings:

  • purulent (not clear) mucus or edema in the middle meatus or ethmoid region
  • polyps in nasal cavity or the middle meatus
  • and/or radiographic imaging showing inflammation of the paranasal sinuses

Exclusion Criteria:

  • Unable to speak English
  • History of nasal or sinus surgery within past 6 weeks
  • History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
  • Dependence on prolonged corticosteroid therapy for comorbid condition
  • History of renal impairment
  • History of cerebrospinal fluid leak

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03243201     History of Changes
Other Study ID Numbers: 159084
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes